Sterility is a transient condition. The sterility of an object can only be understood in relation to the protection of this condition. Packaging is a vital step in the process of obtaining a sterile condition. Packaging means are designed to resist the usual stresses of sterilization, transport and storage in order to allow easy handling and opening.
Several techniques exist for sterilizing medical devices and in particular instruments intended to be in contact with the human body, in particular surgical instruments. Among these techniques there can be mentioned the most commonly used techniques, which are ethylene oxide sterilization, steam sterilization and gas plasma sterilization.
During the sterilization process, the item to be sterilized or the tray of instruments containing the items to be sterilized are first wrapped in a material one of the functions of which is to maintain the sterility of the product once the sterilization stage is complete. This material must prevent any subsequent contamination without reducing the effectiveness of the sterilization stage. The choice of the material is thus dictated by the constraints specific to each sterilization technique.
Two techniques are commonly used in the medical field for wrapping the items to be sterilized or the trays of instruments containing the items to be sterilized.
The first involves wrapping the object to be sterilized with a material suited to the sterilization process by adopting the “Pasteur” folding technique. According to this technique, no sealing is carried out to close the pack, a repeated folding of the material makes it possible to obtain a tortuosity sufficient to maintain the sterility of the pack contents. This technique is particularly suitable for the sterilization of bulky and/or heavy objects. However if the folding is of poor quality, the sterility of the object will not be maintained over time. The maintenance of sterility depends on the quality of the folding. This technique therefore has the disadvantage of depending very largely on human intervention.
The second technique involves placing the object to be sterilized in a peelable pack. Once the object is in the pack, the pack is sealed, then subjected to the sterilization stage. The packs are most often constituted by two separate sheets constituted by different materials. One of the sheets is most often transparent. The packs are suited to the sterilization technique used. The peelable packs being constituted by two heat-sealed sheets, the mechanical strength can be limited by the mechanical strength of the weld which produces the seam between the two sheets, or by the strength of the pack itself.
One of the purposes of an embodiment of the present invention is to provide a peelable sterilization pack which is suitable for bulky and/or heavy objects in order so far as possible to minimize human intervention, and thus the risks of subsequent contamination.